GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM

K070210 · Ohmeda Medical · BTL · Apr 20, 2007 · Anesthesiology

Device Facts

• Record ID: K070210
• Device Name: GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
• Applicant: Ohmeda Medical
• Product Code: BTL · Anesthesiology
• Decision Date: Apr 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The T-piece Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide. For professional use only, by trained clinicians.

Device Story

System provides pulmonary resuscitation for infants; includes suction device for airway/nasal clearance, dual medical gas flowmeters for oxygen/air delivery, and airway pressure manometer. Clinician adjusts Peak Inspiratory Pressure (PIP) via front panel knob; Positive End Expiratory Pressure (PEEP) set via adjustable valve on T-piece patient circuit. Optional air/oxygen blender allows FiO2 adjustment (21-100%). Used in clinical settings by trained clinicians; provides visual pressure feedback throughout respiratory cycle. Facilitates lung pressurization and gas exchange; supports standard neonatal resuscitation protocols.

Clinical Evidence

No clinical data. Bench testing only; device conforms to recognized performance standards for powered emergency ventilators.

Technological Characteristics

Mechanical resuscitation system; includes suction, gas flowmeters, airway pressure manometer, and optional air/oxygen blender. Uses T-piece patient circuit. Manual adjustment of PIP and PEEP. No software or electronic sensing/actuation.

Indications for Use

Indicated for infants requiring pulmonary resuscitation to establish a clear airway, provide oxygen/air-oxygen mixtures, or manual ventilation due to ineffective breathing patterns or failure to meet tissue oxygen/CO2 exchange demands. For professional use by trained clinicians only.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• Ohmeda Medical Infant Resuscitation System (K971243)
• Fisher & Paykel Neopuff Infant Resuscitator (K892885)
• AirShields Resuscitaire (K003335)
• Atom InfaWarmer V505 (K002355)

Submission Summary (Full Text)

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# 070210

### 510(k) Summary

Submitter Information and Date Prepared

APR 2 0 2007

Mary Dadone GE Healthcare 8880 Gorman Road Laurel, MD 20723 USA

410-888-5327

Prepared January 20, 2007

#### Device Identification

Proprietary Name: Giraffe and Panda T-piece Resuscitation System Common Name: Powered Emergency Ventilator (Resuscitator) Classification Name: Powered emergency ventilator (21 CFR 868.5925)

#### Predicate Device Information

The Giraffe and Panda T-piece Resuscitation System is substantially equivalent to the following predicate devices:

| Predicate Device | Last 510(k) Number |
|---------------------------------------------|--------------------|
| Ohmeda Medical Infant Resuscitation System | K971243 |
| Fisher & Paykel Neopuff Infant Resuscitator | K892885 |
| AirShields Resuscitaire | K003335 |
| Atom InfaWarmer V505 | K002355 |

#### Intended Use Statement

The T-piece Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.*

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Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.

For professional use only, by trained clinicians.

* As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 5th Edition.

#### Functional Description and Technological Characteristics

The T-piece Resuscitation System incorporates the following features for the practice of infant resuscitation: a suction device for clearance of the trachea and nasal passages; two medical gas flowmeters to deliver oxygen or air/oxygen mixtures to the infant requiring such therapy; and an airway pressure manometer. An optional air/oxygen blender including high-pressure yokes may be included with the system which allows the clinician to adjust FiO2 % from 21-100%.

The airway pressure manometer allows a trained clinician to see pressure throughout the respiratory cycle.

Peak Inspiratory Pressure (PIP) is adjusted using the PIP knob located on the front panel of the resuscitation system that allows the clinician to set the maximum pressure being delivered to the infant in order to facilitate adequate pressurization of the lungs.

Positive End Expiratory Pressure (PEEP) can be set using the adjustable PEEP valve located on the T-piece patient circuit.

The T-piece resuscitation system is intended for use only with GE Healthcare Tpiece resuscitation circuits.

#### Performance Data

Pulmonary resuscitation of infants includes well established clinical practices; animal or clinical testing to support safety and effectiveness is not necessary. The conformance of the Giraffe and Panda T-piece Resuscitation System to performance specifications and to multiple recognized performance standards is being established through bench testing.

Prepared by: *Mary Osborne* and the following is the response:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Agata Smieja Global Compliance Leader Maternal Infant Care, Clinical Systems, GE Healthcare 8880 Gorman Road Laurel, Maryland 20723

APR 2 0 2007

Re: K070210

Trade/Device Name: Giraffe and Panda T-Piece Resuscitation System Regulation Number: 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: March 29, 2007 Received: April 2, 2007

Dear Ms. Smieja:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Ms. Smieja

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Aryite y. Michael Dms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Giraffe and Panda T-piece Resuscitation System Device Name:

Indications for Use:

The T-piece Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care. *

Resuscitation may be required whenever an infant fails to establish effective, adequate breathing patterns necessary to meet tissue oxygen demands and/or to rid the body of carbon dioxide.

For professional use only, by trained clinicians.

* As stated in collaborative guidelines written by the American Heart Association (AHA) and the American Academy of Pediatrics (AAP) in the Textbook of Neonatal Resuscitation, 54 Edition.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Chullo

cinesiology, General Hosp. 3. Contral Demost Kuvices

S(K) Number: K070210

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